scholarly journals The TANDEM trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety and/or depression in people living with chronic obstructive pulmonary disease (COPD)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Moira Kelly ◽  
Liz Steed ◽  
Ratna Sohanpal ◽  
Hilary Pinnock ◽  
Amy Barradell ◽  
...  

Abstract Background TANDEM is a randomised controlled trial of a complex healthcare intervention to improve the psychological and physical health of people living with chronic obstructive pulmonary disease (COPD) and anxiety and/or depression. Based on health psychology theory set out in a logic model, respiratory health professionals were recruited and trained to deliver a cognitive behavioural approach intervention (The TANDEM intervention) under the supervision of senior cognitive behavioural practitioners. Here, we describe the protocol for the process evaluation commissioned alongside the trial. A realist approach that includes attention to describing contexts and mechanisms has been adopted. Methods We set up a multi-disciplinary team to develop and deliver the process evaluation. The mixed-methods design incorporates quantitative process data; monitoring of intervention fidelity; qualitative interviews with patients, carers, health professionals (facilitators) and clinical supervisors about their perspectives on acceptability of the intervention; and exploration with all stakeholders (including management/policy-makers) on future implementation. Normalisation process theory (NPT) will inform data collection and interpretation with a focus on implementation. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before the trial outcomes are known using analytic induction and constant comparison to develop themes. Findings from the different elements will be reported separately and then integrated. Conclusion Detailed description and analysis of study processes in a research trial such as TANDEM enables research teams to describe study contexts and mechanisms and to examine the relationship with outcomes. In this way, learning from the trial goes beyond the randomised control trial (RCT) model where effectiveness is prioritised and makes it possible to explore issues arising for post-trial study implementation. Trial registration ISRCTN ISRCTN59537391. Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018. Process evaluation protocol version 4.0, 1 November 2020.

2021 ◽  
Author(s):  
Moira Kelly ◽  
Liz Steed ◽  
Ratna Sohanpal ◽  
Hilary Pinnock ◽  
Amy Barradell ◽  
...  

Abstract Background TANDEM is a randomised controlled trial of a complex healthcare intervention to improve the psychological and physical health of people living with chronic obstructive pulmonary disease (COPD) and anxiety and/or depression. Based on health psychology theory set out in a logic model, respiratory health professionals were recruited and trained to deliver a cognitive behavioural approach intervention (The TANDEM intervention) under the supervision of senior cognitive behavioural practitioners. Here we describe the protocol for the process evaluation commissioned alongside the trial. A realist approach that includes attention to describing contexts and mechanisms has been adopted. Methods We set up a multi-disciplinary team to develop and deliver the process evaluation. The mixed-methods design incorporates quantitative process data; monitoring of intervention fidelity; qualitative interviews with patients, carers, health professionals (facilitators) and clinical supervisors about their perspectives on acceptability of the intervention; exploration with all stakeholders (including management/policy-makers) on future implementation. Normalization process theory (NPT) will inform data collection and interpretation with a focus on implementation. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before the trial outcomes are known using analytic induction and constant comparison to develop themes. Findings from the different elements will be reported separately and then integrated. Conclusion Detailed description and analysis of study processes in a research trial such as TANDEM enables research teams to describe study contexts and mechanisms, and to examine the relationship with outcomes. In this way learning from the trial goes beyond the randomised control trial (RCT) model where effectiveness is prioritised and makes it possible to explore issues arising for post-trial study implementation. Trial registration ISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018.


Author(s):  
Débora Rafaelli de Carvalho ◽  
Larissa Araújo de Castro ◽  
Andrea Akemi Morita ◽  
Walter Sepúlveda Loyola ◽  
Dirce Shizuko Fujisawa ◽  
...  

2021 ◽  
Vol 23 (2) ◽  
pp. 1-4
Author(s):  
Mark Greener

About one million people in the UK have diagnosed chronic obstructive pulmonary disease and live with persistent, unpleasant and often debilitating symptoms. The condition is common among nursing home residents, yet is often poorly recognised by the general public and even by some health professionals. Recent research highlights why nursing and residential care staff should remain vigilant for this common respiratory condition.


2019 ◽  
Vol 6 (1) ◽  
pp. e000444
Author(s):  
Anita Jayadev ◽  
Robert Stone ◽  
Michael C Steiner ◽  
Viktoria McMillan ◽  
C Michael Roberts

BackgroundRandomised control trial (RCT)-derived survival figures for acute exacerbation of chronic obstructive pulmonary disease admissions managed with non-invasive ventilation (NIV) have not been replicated in UK clinical audits. Subsequent guidelines have emphasised the need for timely NIV application.MethodsData from the 2008 and 2014 national chronic obstructive pulmonary disease audits was used to analyse the association between time to NIV and mortalityResults1032 patients received NIV in 2008, and 1612 in 2014. Overall mortality rates reduced between the audits from 24.9% in 2008 to 16.8% in 2014 but time to NIV lengthened. In 2014, 20.9% of patients received NIV within 60 min versus 24.9% in 2008 (p=0.001). The proportion of patients receiving NIV between 3 and 24 hours increased from 31.3% in 2008 to 39% in 2014 (p=0.001). Patients admitted with hypercapnic acidotic respiratory failure who received NIV within 3 hours had lower in-patient mortality than those who received NIV between 3 and 24 hours, 15.9% versus 18.4%, but this did not reach statistical significance (p=0.425), but acidotic patients receiving NIV >24 hours after admission had significantly higher mortality (28.9%, p=0.002). A second cohort admitted with hypercapnia but normal range pH, who developed later acidosis, had higher mortality (24.6%), compared with those acidotic on admission (18% p≤0.001) and an extremely high mortality when NIV was given >24 hours after admission (42.6%).ConclusionSurvival rates for those treated with NIV has improved between the two audits but remains lower than reported in RCTs. Patients who developed acidosis after admission and received NIV later in the hospital stay have even higher mortality and deserve further study and clinical attention.


2018 ◽  
Vol 16 ◽  
pp. 147997311881642 ◽  
Author(s):  
Shannon Storey ◽  
Bircan Erbas ◽  
Anne Elizabeth Holland

Many people with chronic obstructive pulmonary disease (COPD) undertake pulmonary rehabilitation more than once. This study examined patient experiences and health professional perspectives regarding repeating pulmonary rehabilitation. Participants were 14 patients with COPD and 15 health professionals. Patients had undertaken pulmonary rehabilitation at a tertiary hospital; health professionals were doctors, physiotherapists, and nurses. Semi-structured interviews were conducted, and data were analyzed using thematic analysis. Patients described improved fitness and better breathing after repeating pulmonary rehabilitation; however, some also reported that repeating required confronting their disease progression. Improved confidence and motivation were an important outcome of repeating. Although most participants had attended community-based exercise classes, they valued the greater intensity of exercise and closer supervision that came with repeating pulmonary rehabilitation. Health professionals reported referring patients to repeat pulmonary rehabilitation if they had worsening functional capacity, an exacerbation, or hospitalization. There was no agreement regarding the optimal time for repeating and many would only re-refer if the patient demonstrated motivation to attend. In conclusion, patients with COPD reported many symptomatic benefits from repeating pulmonary rehabilitation and gained confidence from a supervised program. There was no agreement between health professionals regarding the optimal time to repeat pulmonary rehabilitation.


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